Back to jobs
Manufacturing Quality Engineer IV
- Posted 24 January 2025
- LocationHuntington Beach
- Job type Permanent
- Reference210210
- Contact NameJeremy Burling
Job description
Manufacturing Quality Engineer IV
The Manufacturing Quality Engineer IV (MQE IV) will be an integral member of my client's quality team in supporting the quality-related activities associated with the manufacture, test, and distribution of the class III implantable medical device they are working on. The MQE IV will also work with my client's senior management to determine production standards for my client's product by establishing quality control systems for manufacturing and setting production requirement rules.
The MQE IV will assist in the management of daily QA activities including developing and performing of validation & verification tests, completion of incoming, in-process and final inspection of assemblies and devices. The MQE IV will work with internal engineering staff from mechanical, electrical, and software engineering backgrounds to support manufacturing process development and maintenance. The MQE IV may also assist with elements of design control such as requirements, system hazards analysis, design and process FMEAs. The MQE will act as a liaison between my client and external suppliers to ensure QA activities are sufficiently undertaken to support product development. The MQE IV will identify and record potential problems relating to the product, process, and Quality System. The MQE IV will initiate, recommend or provide solutions through designated channels. The MQE IV will then record and/or report all instances of customer feedback on the product. The MQE IV will finally verify the implementation of solutions.
My client is looking for motivated team members who are keen to contribute to this active and dynamic project. This role requires creativity and flexibility, strong organizational, time management, and technical skills. Analytical and problem-solving skills with the ability to multitask in a deadline-driven environment, while working with minimal or no supervision is essential.
RESPONSIBILITIESQuality System Support:
Complaint handling and investigation
CAPA handling and investigation
Guidance for completion of failure investigations
Implement and support quality improvement models, corrective and preventive action, overcoming barriers to quality improvement.
Participation in external audits – develop response to queries during and following the audit.
Initiate action to prevent the occurrence of non-conformities relating to the product, process, and quality system and follow through the non-conformance and failure investigation process affecting Quality, and report verbally and in writing to the executive team regarding the progress and results of projects.
REQUIREMENTS
Manufacturing Quality Engineer IV
The Manufacturing Quality Engineer IV (MQE IV) will be an integral member of my client's quality team in supporting the quality-related activities associated with the manufacture, test, and distribution of the class III implantable medical device they are working on. The MQE IV will also work with my client's senior management to determine production standards for my client's product by establishing quality control systems for manufacturing and setting production requirement rules.
The MQE IV will assist in the management of daily QA activities including developing and performing of validation & verification tests, completion of incoming, in-process and final inspection of assemblies and devices. The MQE IV will work with internal engineering staff from mechanical, electrical, and software engineering backgrounds to support manufacturing process development and maintenance. The MQE IV may also assist with elements of design control such as requirements, system hazards analysis, design and process FMEAs. The MQE will act as a liaison between my client and external suppliers to ensure QA activities are sufficiently undertaken to support product development. The MQE IV will identify and record potential problems relating to the product, process, and Quality System. The MQE IV will initiate, recommend or provide solutions through designated channels. The MQE IV will then record and/or report all instances of customer feedback on the product. The MQE IV will finally verify the implementation of solutions.
My client is looking for motivated team members who are keen to contribute to this active and dynamic project. This role requires creativity and flexibility, strong organizational, time management, and technical skills. Analytical and problem-solving skills with the ability to multitask in a deadline-driven environment, while working with minimal or no supervision is essential.
RESPONSIBILITIES Quality System Support:
Complaint handling and investigation
CAPA handling and investigation
Guidance for completion of failure investigations
Implement and support quality improvement models, corrective and preventive action, overcoming barriers to quality improvement.
Participation in external audits – develop response to queries during and following the audit.
Initiate action to prevent the occurrence of non-conformities relating to the product, process, and quality system and follow through the non-conformance and failure investigation process affecting Quality, and report verbally and in writing to the executive team regarding the progress and results of projects.
REQUIREMENTS
The Manufacturing Quality Engineer IV (MQE IV) will be an integral member of my client's quality team in supporting the quality-related activities associated with the manufacture, test, and distribution of the class III implantable medical device they are working on. The MQE IV will also work with my client's senior management to determine production standards for my client's product by establishing quality control systems for manufacturing and setting production requirement rules.
The MQE IV will assist in the management of daily QA activities including developing and performing of validation & verification tests, completion of incoming, in-process and final inspection of assemblies and devices. The MQE IV will work with internal engineering staff from mechanical, electrical, and software engineering backgrounds to support manufacturing process development and maintenance. The MQE IV may also assist with elements of design control such as requirements, system hazards analysis, design and process FMEAs. The MQE will act as a liaison between my client and external suppliers to ensure QA activities are sufficiently undertaken to support product development. The MQE IV will identify and record potential problems relating to the product, process, and Quality System. The MQE IV will initiate, recommend or provide solutions through designated channels. The MQE IV will then record and/or report all instances of customer feedback on the product. The MQE IV will finally verify the implementation of solutions.
My client is looking for motivated team members who are keen to contribute to this active and dynamic project. This role requires creativity and flexibility, strong organizational, time management, and technical skills. Analytical and problem-solving skills with the ability to multitask in a deadline-driven environment, while working with minimal or no supervision is essential.
RESPONSIBILITIES
- Ensure that processes adhere to quality standards and are compliant with 21 CFR 820, 803, 806, and ISO 13485.
- Determine quality improvement factors and opportunities.
- Implementing methods to inspect, test, and evaluate the reliability of manufacturing processes, products, and production equipment.
- Prepare reports by collecting, analyzing, and summarizing data.
- Work in accordance with deadlines for delivery of products and software.
- Promote awareness of the Quality System and provide training to individuals across the organization on quality management philosophies, tools, techniques, and best practices.
- Provide training and direction, as required, to junior team members within the organization.
- Implement quality methods throughout the organization, drive the use of quality tools in operation and product development, assist in resolving major product-related issues.
- Create, edit, and maintain documentation related to design controls and quality system guidelines.
- Assist in the development of design input specifications and study designs.
- Write and review Standard Operating Procedures (SOPs) and Work Instructions (WIs).
- Define, develop, and implement processes and technical solutions to support product and process quality in accordance with quality principles which includes material control, acceptance sampling, and measurement systems.
- Assist with the development and validation of test methods addressing the User Needs and Design Specifications.
- With the assistance of Quality and Regulatory personnel prepare and maintain documentation suitable for regulatory submissions for IDE human clinical studies.
- Support preparation and maintenance of compliance to ISO 14971 Risk Management. Assist in conducting risk management activities and updating FTA, FMEA, etc.
- Coordinate and oversee sterilization validation activities.
- Coordinate and oversee maintenance of clean room environments (min. class 8).
- Review and approve Device History Records.
- Assist with the implementation and validation efforts for new facility locations, new/changed materials, equipment, processes, and components.
- Ensure systematic planning, and controlling of product and process quality in manufacturing processes for planning product and service development, material control, acceptance activities, and measurement systems.
- Conduct inspection of components and subassemblies as required and document compliance to approved specifications and procedures.
- Initiate and coordinate laboratory testing of raw materials, assemblies, finished goods, and environmental conditions.
- Interact with external suppliers:
- Develop quality agreements and quality control plans in collaboration with suppliers.
- Lead supplier audits and participate in supplier visits.
- Develop responses to queries during and following the audit.
- Bachelor’s degree or higher in Biomedical Engineering or similar, 8+ years of work experience in medical device development or quality assurance.
- At least 5 years working at a class II or III medical device company. Ventricular Assist Device experience would be highly valued.
- Experience with electrical/mechanical systems for medical devices in a regulated environment.
- Through understanding of design control requirements, verification, and validation for medical devices.
- Thorough understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics.
- Thorough understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards and requirements.
- Thorough understanding of the audit process, including types of audits, planning, preparation, execution, reporting results, and follow-up.
- Thorough understanding of problem-solving and quality improvement tools and techniques, including management and planning tools, preventive and corrective actions, and how to overcome barriers to quality improvements.
- Thorough knowledge of statistical analysis, reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools, and reporting.
- Working knowledge of quality systems, risk management tools, and applicable standards, such as FMEA, QSR, ISO 14708, ISO 17025, ISO 14971, ISO 13485, 21 CFR Part 820, 803, 806.
- Working knowledge of gauges and precision inspection equipment/instruments.
- Experience in a Design Assurance role with experience through all phases (from product conception through commercialization) desirable.
- Proficient with Microsoft Office. Experience with project planning software packages, DAQ systems, and interface with Matlab is highly desirable.
- Desirably holds certification/qualification from the American Society for Quality: CQE, CRE, CSQE, or CBA.
Manufacturing Quality Engineer IV
The Manufacturing Quality Engineer IV (MQE IV) will be an integral member of my client's quality team in supporting the quality-related activities associated with the manufacture, test, and distribution of the class III implantable medical device they are working on. The MQE IV will also work with my client's senior management to determine production standards for my client's product by establishing quality control systems for manufacturing and setting production requirement rules.
The MQE IV will assist in the management of daily QA activities including developing and performing of validation & verification tests, completion of incoming, in-process and final inspection of assemblies and devices. The MQE IV will work with internal engineering staff from mechanical, electrical, and software engineering backgrounds to support manufacturing process development and maintenance. The MQE IV may also assist with elements of design control such as requirements, system hazards analysis, design and process FMEAs. The MQE will act as a liaison between my client and external suppliers to ensure QA activities are sufficiently undertaken to support product development. The MQE IV will identify and record potential problems relating to the product, process, and Quality System. The MQE IV will initiate, recommend or provide solutions through designated channels. The MQE IV will then record and/or report all instances of customer feedback on the product. The MQE IV will finally verify the implementation of solutions.
My client is looking for motivated team members who are keen to contribute to this active and dynamic project. This role requires creativity and flexibility, strong organizational, time management, and technical skills. Analytical and problem-solving skills with the ability to multitask in a deadline-driven environment, while working with minimal or no supervision is essential.
RESPONSIBILITIES
- Ensure that processes adhere to quality standards and are compliant with 21 CFR 820, 803, 806, and ISO 13485.
- Determine quality improvement factors and opportunities.
- Implementing methods to inspect, test, and evaluate the reliability of manufacturing processes, products, and production equipment.
- Prepare reports by collecting, analyzing, and summarizing data.
- Work in accordance with deadlines for delivery of products and software.
- Promote awareness of the Quality System and provide training to individuals across the organization on quality management philosophies, tools, techniques, and best practices.
- Provide training and direction, as required, to junior team members within the organization.
- Implement quality methods throughout the organization, drive the use of quality tools in operation and product development, assist in resolving major product-related issues.
- Create, edit, and maintain documentation related to design controls and quality system guidelines.
- Assist in the development of design input specifications and study designs.
- Write and review Standard Operating Procedures (SOPs) and Work Instructions (WIs).
- Define, develop, and implement processes and technical solutions to support product and process quality in accordance with quality principles which includes material control, acceptance sampling, and measurement systems.
- Assist with the development and validation of test methods addressing the User Needs and Design Specifications.
- With the assistance of Quality and Regulatory personnel prepare and maintain documentation suitable for regulatory submissions for IDE human clinical studies.
- Support preparation and maintenance of compliance to ISO 14971 Risk Management. Assist in conducting risk management activities and updating FTA, FMEA, etc.
- Coordinate and oversee sterilization validation activities.
- Coordinate and oversee maintenance of clean room environments (min. class 8).
- Review and approve Device History Records.
- Assist with the implementation and validation efforts for new facility locations, new/changed materials, equipment, processes, and components.
- Ensure systematic planning, and controlling of product and process quality in manufacturing processes for planning product and service development, material control, acceptance activities, and measurement systems.
- Conduct inspection of components and subassemblies as required and document compliance to approved specifications and procedures.
- Initiate and coordinate laboratory testing of raw materials, assemblies, finished goods, and environmental conditions.
- Interact with external suppliers:
- Develop quality agreements and quality control plans in collaboration with suppliers.
- Lead supplier audits and participate in supplier visits.
- Develop responses to queries during and following the audit.
- Bachelor’s degree or higher in Biomedical Engineering or similar, 8+ years of work experience in medical device development or quality assurance.
- At least 5 years working at a class II or III medical device company. Ventricular Assist Device experience would be highly valued.
- Experience with electrical/mechanical systems for medical devices in a regulated environment.
- Through understanding of design control requirements, verification, and validation for medical devices.
- Thorough understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics.
- Thorough understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards and requirements.
- Thorough understanding of the audit process, including types of audits, planning, preparation, execution, reporting results, and follow-up.
- Thorough understanding of problem-solving and quality improvement tools and techniques, including management and planning tools, preventive and corrective actions, and how to overcome barriers to quality improvements.
- Thorough knowledge of statistical analysis, reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools, and reporting.
- Working knowledge of quality systems, risk management tools, and applicable standards, such as FMEA, QSR, ISO 14708, ISO 17025, ISO 14971, ISO 13485, 21 CFR Part 820, 803, 806.
- Working knowledge of gauges and precision inspection equipment/instruments.
- Experience in a Design Assurance role with experience through all phases (from product conception through commercialization) desirable.
- Proficient with Microsoft Office. Experience with project planning software packages, DAQ systems, and interface with Matlab is highly desirable.
- Desirably holds certification/qualification from the American Society for Quality: CQE, CRE, CSQE, or CBA.
